HPVPhase 4NOVA-HIVNCT05495906
A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV
A Phase 4 study testing Nonavalent HPV vaccine in people with HPV and Human Papilloma Virus, run by University of British Columbia at 10 sites in Canada.
Trial summary
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Human Papilloma Virus, Human Immunodeficiency Virus
- What is being tested?
- Nonavalent HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 10 sitesCanada
- Study dates
- 27 Jul 2023to Jan 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living with HIV
- Has a uterine cervix
Who cannot join
- Unable to give fully informed consent
- Pregnant or unwilling to avoid pregnancy during vaccination
- Allergy to the vaccine or its components
- Prior receipt of any HPV vaccine
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Not yet recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8S1A4
Mariana Rusler, BSc Psych., CCRA, 905-521-2100 ext. 73443, rusler@hhsc.ca
Shariq Haider, MD
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T1C5
Hasna Meddour, 514-345-4931 ext. 7169, Hasna.Meddour@recherche-ste-justine.qc.ca
Suzanne Taillefer, PhD, suzanne.taillefer.hsj@ssss.gouv.qc.ca
- Not yet recruiting
McGill University Health Centre
Montreal, Quebec, H4A3J1
Nathalie Paisible, R.N., 514-934-1934 ext. 32537, nathalie.paisible@muhc.mcgill.ca
Hansi Peiris, 514-934-1934 ext. 32547, hansi.peiris@muhc.mcgill.ca
- Recruiting
Centre Hospitalier de l'Université Laval
Québec, Quebec, G1V4G2
Isabelle Chabot, 418-525-4444 ext. 47778, isabelle.chabot@crchudequebec.ulaval.ca
Geneviève Gagnon, R.N., 418-525-4444 ext. 48914
- Not yet recruiting
Regina General Hospital
Regina, Saskatchewan, S4P0W5
Danielle Myrah, RN, BScN, 306-766-3915, Danielle.Myrah@saskhealthauthority.ca
Sarah Craddock, CHIM, 306-766-0576, Sarah.Craddock@saskhealthauthority.ca
- Not yet recruiting
Positive Health Services - Fraser Health
Surrey, British Columbia, V3T 0G9
Henry Payette, BSc, henry.payette@cw.bc.ca
Michael Chapman, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Klaudia Szczech, MSc, 416-867-7460 ext. 49092, klaudia.szczech@unityhealth.to
Arifa Rahman, M.B.B.S, MPH, 416-867-7460 ext. 48047, arifa.rahman@unityhealth.to
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G2C4
Adriana D'Aquila, R.N., 416-340-4800 ext. 8170, Adri.DAquila@uhn.ca
Sharon Walmsley, MD
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6H 2N1
Deborah Money, MD, 6048752194, deborah.money@ubc.ca
Emma Karlsen, BSc, 604-875-2424 ext. 6379, emma.karlsen@cw.bc.ca
- Not yet recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Dozie Ochular, 204-975-7723, Dozie.Ochulor@umanitoba.ca
Sudharsana R Ande, PhD, 204-975-7723, sande@hsc.mb.ca
About this study
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally.
This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time.
This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
- Conditions
- HPV, Human Papilloma Virus, Human Immunodeficiency Virus
- Being tested
- Nonavalent HPV vaccine
- Keywords
- HPV vaccination
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonavalent HPV vaccineBiological
Also called Gardasil9
Routine dosing form and dosage
| Study group | Role | What they receive |
|---|---|---|
| Routine schedule | Active comparator | Three doses of 9vHPV vaccine at the routine dosing schedule of 0/2/6 months Receives: Biological: Nonavalent HPV vaccine |
| Extended schedule | Experimental | Two doses of 9vHPV vaccine at an expanded dosing schedule of 0/6 months with a third dose given at month 12 Receives: Biological: Nonavalent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV16/18 geometric mean titers (GMTs) at month 7
Anti-HPV16/18 GMTs at month 7 (1 month post 3rd dose in Group 1 and 1 month post 2nd dose in Group 2)
Measured: Month 7
Secondary outcomes (2)
Anti-HPV16/18 GMTs at month 24 in both groups (i.e. routine and extended interval)
Measured: Month 24
Quantitative summarization of survey responses regarding vaccine acceptability, comfort, and willingness to use HPV self-sampling as a screening methodology in future
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start27 Jul 2023
- Primary completionAug 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Money, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495906
- Sponsor's protocol ID
- H22-01707
- Acronym
- NOVA-HIV
- Status last verified
- Feb 2026
- First submitted
- 8 Aug 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No